Spots Global Cancer Trial Database for Discontinuation Study of Imatinib in Adult CP CML Patients Who Have a Complete Molecular Response to Imatinib

Study Description

Brief Summary: This prospective study is performed to identify safer and more concrete indicators of successful discontinuation and explore contributing factors for sustained undetectable transcript

Detailed Description: Imatinib (IM) treatment has been the standard of care for chronic phase (CP) chronic myeloid leukemia (CML) and approximately 50% of CP CML patients who received IM treatment achieve complete molecular response (CMR) at 6-7 years.(Hochhaus A et al. Leukemia 2009;23:1054-1061, Hughes et al. Blood 2008;112:334) The recent data from a study aimed to assess whether IM can be discontinued in patients with a CMR lasting at least 2 years showed the probability of persistent CMR at 12 months was 41%, and suggested IM can be safely discontinued, at least in some patients with sustained CMR. (Mahon et al. Lancet Oncol 2010;11:1029-1035) However, to define whether discontinuation of IM treatment can be safely employed, further validation and much longer follow-up are needed. Aims This prospective study is performed to identify safer and more concrete indicators of successful discontinuation and explore contributing factors for sustained undetectable transcript. Primary Objective: * To evaluate the probability of persistent undetectable molecular residual disease (UMRD) and MR4.5 at 12 months after discontinuation * To measure the duration of persistent UMRD and MR4.5 after discontinuation * To identify contributing factors for sustained undetectable transcript Secondary Objective: * To evaluate the probability of major molecular response (MMR) loss * To evaluate the time taken to lose MMR at 12 months after discontinuation * In patients with loss of MMR, the probability of re-achieving MMR/MR4.5 * To measure the time taken to re-achieve MMR/MR4.5 after IM resumption * To identify contributing factors for sustained re-achieve MMR/MR4.5 Trial Design This is a prospective, multicenter, non-randomised IM discontinuation study. Response Evaluation After discontinuation, molecular response was monitored using RQ-PCR assay every month up to 6 month follow-up, every 2 months up to 12 month follow-up, and every 3 months thereafter. The loss of MMR, MR4.5, and UMRD were defined on 2 consecutive assessments. If loss of MMR occurred, IM treatment was re-introduced. Written informed consents were obtained for all patients

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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